Recall Z-2357-2024 ยท HWJ Awl
SEASPINE ORTHOPEDICS CORPORATION
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
| Date | Jul 15, 2024 (initiated Jun 4, 2024) |
| Status | Open, Classified |
| Reason | Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces. |
| Root cause | Process design |
| Action | On June 4, 2024, SeaSpine Orthopedics issued a "Urgent Medical Device Recall" Notification via E-Mail to affected consignees. SeaSpine Orthopedics ask consignees to take the following actions: We request that you return the affected part to SeaSpine s Carlsbad facility for evaluation and potential rework. To support your upcoming cases, a replacement Vu aPod Prime NM Angled Awl will be sent (PN: 33-40-1028). Additionally, please continue to utilize the loaner pool. Please use the attached label to return the inventory in your possession at your earliest convenience. Once the inventory has be |
| Quantity | 100 units |
| Distribution | The product was distributed to the following US states: Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Missouri, South Dakota, California, Montana, Minnesota, Arizona |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.